Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

This study has been terminated.
(New sponsor, other treatments available)
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00127881
First received: August 8, 2005
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.


Condition Intervention Phase
Mycosis Fungoides
Sezary Syndrome
Drug: HuMax-CD4 (zanolimumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

Resource links provided by NLM:


Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • PGA Score [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: July 2005
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zanolimumab Drug: HuMax-CD4 (zanolimumab)
Monoclonal Antibody, 12 weekly infusions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
  • Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
  • Signed informed consent

Exclusion Criteria:

  • Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
  • Prior treatment with Campath (alemtuzumab)
  • Prior treatment with more than three regimens of single agent chemotherapy
  • Prior treatment with pentostatin within 6 months
  • Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
  • Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
  • Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease
  • Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
  • Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
  • Known or suspected positive serology for HIV
  • Known or suspected positive serology for hepatitis B or C
  • Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
  • Prior treatment with anti-CD4 monoclonal antibodies
  • Breast feeding women or women with a positive pregnancy test at Visit 1
  • Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane University Health Science Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New York
New York Medical Center
New York, New York, United States, 10016
Memorial Sloan Kettering
New York City, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43201
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Middle Tennessee Research Institute
Nashville, Tennessee, United States, 37212-2637
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
France
Hopital de I'Hotel-Dieu
Lyon Cedex 02, France, 69288
Consultation Dermatologie Niveau moins 1 Hopital Archet 2
Nice, France, 06220
Hopital Saint-Louis Service de Dermatologie
Paris Cedex 10, France, 75475
Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
Pierre Benite Cedex, France, 69495
Germany
Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
Berlin, Germany, 10117
University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
Essen, Germany, 45122
University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
Kiel, Germany, D-24105
Klinikum Minden / Hautklinik Minden
Minden, Germany, 32427
University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
Wurzburg, Germany, 97080
Italy
Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
Bologna, Italy, 40138
Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
Florence, Italy, 50121
University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
Milan, Italy, 20122
Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
Roma, Italy, 00167
University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
Turin, Italy, 10126
Spain
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Maternidad Planta Baja, Hospital 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Emergent Product Development Seattle LLC
  More Information

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00127881     History of Changes
Other Study ID Numbers: Hx-CD4-110
Study First Received: August 8, 2005
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emergent Product Development Seattle LLC:
Refractory or intolerant to Mycosis Fungoides and sezary syndrome
Cutaneous T-cell Lymphoma
To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome

Additional relevant MeSH terms:
Syndrome
Mycoses
Mycosis Fungoides
Sezary Syndrome
Disease
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014